April 17, 2023

NRG Oncology Broadcast archives are accessible from our website at any time. Please bookmark this link for your convenience.

AMENDMENTS

GASTROINTESTINAL

NRG-GI004/SWOG S1610: Amendment 9; version date: February 20, 2023 (posted on CTSU)

CLOSURES

GYNECOLOGIC

NRG-GY023: Permanent Closure to accrual effective February 1, 2023; version date: August 23, 2022. Investigator and Patient Letters are posted on CTSU. 

OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

NRG-GY022: Reminder: Actively Recruiting MALE Patients only Read More

2. BRAIN

NRG-BN010: The study has reopened to the safety run-in portion, dose level 3. Please refer to the Reopening Study Memorandum dated April 10, 2023, on the CTSU website.

3. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: The FORTE study team has created talking points for research professionals containing tips and tricks to assist with accrual efforts. Review the NRG-CC005/FORTE Coordinator Talking Points (posted on CTSU) to learn from successfully accruing sites and coordinators today!

NRG-CC005/FORTE: Join the next FORTE site call on May 17 at 4pm EDT, an informal discussion on study progress and conduct with the NRG FORTE team, featuring Kaiser Permanente representatives to share about their screening and enrolling process. Register today at this link! 

4. GASTROINTESTINAL

NRG-GI004/SWOG S1610 (COMMIT): The Amendment 9 Overview webinars are being held on May 16 at 10am EDT and 4pm EDT. Please see the memorandum (posted on CTSU) for details and how to register for one of the sessions.

.

NRG-GI005 (COBRA) / NRG-GI008 (CIRCULATE-US): The webinar “Surgical implications of ctDNA: Is this the future for colon cancer?” is being held on April 26 and May 4. Please visit the NRG Oncology website or see the memorandum (posted on CTSU) for details and how to register for one of the sessions.

5. GENITOURINARY

NRG-GU008, NRG-GU009, NRG-GU010, NRG-GU011 – Please remember to submit an updated Study Agent Shipment Form (SASF) via the CTSU Regulatory Submission portal when there are personnel changes that affect the drug shipment for these trials. This will help the drug distributor and NRG process the drug orders in a timely manner.

6. GYNECOLOGIC

GOG-0210: Reminder: Biospecimens, biomarker data, clinical data, and epidemiologic data are available for request. Please visit the NRG Oncology website for more information on this important study with the overall goal of improving the outcome and/or quality of life for patients with endometrial cancer.

NRG-GY012 and NRG-GY023 – Reminder: BLOOD PRESSURE CUFF SUPPLY IS VERY LIMITED - Please be advised that VWR has a very limited supply of blood pressure cuffs at present. Please check your supplies on site for any overlooked cuffs prior to ordering. Thank you for your cooperation. 

Printing Biospecimen Transmittal PDFs on GYN Trials

Please note an effort is underway to clarify how to obtain a Biospecimen Transmittal PDF for submission to the NRG Oncology Biospecimen Bank. Read More

7. HEAD & NECK

NRG-HN008

Reminder: please update treatment and AE data weekly. This is a Phase I trial and timely data submission is very important. 

8. VTOC TRAINING

The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, NRG-HN002, NRG-CC003, NRG-CC005 and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, May 3, 2023. 

DRUG SAFETY AND INVESTIGATOR'S BROCHURE (IB) UPDATES

Drug Safety and Investigator’s Brochure updates have been issued for the following studies:

*The current version of the Investigator Brochure Documents for Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)-sponsored trials are available for access via the Cancer Therapy Evaluation Program (CTEP) Online Agent Order Processing (OAOP) website. Log-in using your Identity and Access Management (IAM) username and password credentials and provide the requested information to access the document.

Every site principal investigator is responsible for reviewing this document. The Investigator Brochure is for use by the site principal investigator and any study personnel under his/her supervision who need to know the contents for the conduct of a clinical trial, including Institutional Review Board(s) or Independent Ethics Committee(s).

1. An Update from NRG Oncology Quality Assurance

The NCI Guidelines for Auditing Clinical Trials for the NCI National Clinical Trials Network have been updated with an effective date of Monday, April 10, 2023. The updated NCI Audit Guidelines and a summary of changes to support the current version can be found by clicking here.

2. NRG Record Retention Guidance for NCTN and NCORP Trials

An updated NRG Record Retention Guidance for NCTN and NCORP trials was recently added to the NRG Oncology website Policies & Bylaws page. 

3. Special BIQSFP Funding Announcement for Non-real Time Integrated The NCI has announced the opportunity to submit for supplements to fund non-real time (NRT) integrated studies associated with NCTN or NCORP-supported studies. Each group is allowed to submit up to 3 proposals for NCTN and up to 2 proposals for NCORP. Read more and learn how to apply here.

4. Request for NCORP pilot project applications

Date Issued: February 17, 2023

Submission Due Date: April 21, 2023

NRG Oncology NCORP solicits PILOT projects addressing NRG NCORP Cancer Care Delivery Research (CCDR), Cancer Prevention and Control (CPC) Research and Health Disparities Research (HDR) priorities. PILOT projects should generate preliminary data and address feasibility issues to inform the development of a future NCORP concept. Refer to the links below for further details.

Cancer Care Delivery Research (CCDR)

Cancer Prevention and Control (CPC)

Health Disparities Research (HDR)

5. NRG Cancer Care Delivery Webinar – Register today!

Register for the upcoming webinar hosted by the NRG Cancer Care Delivery Committee: Advancing equity in artificial intelligence for cancer care delivery

Cancer care delivery increasingly employs artificial intelligence tools to improve diagnosis, treatment selection, and health system efficiency. As tool integration progresses in clinical care settings, practitioners should be intentional about equitable implementation and knowledgeable about algorithmic fairness, which may exacerbate current health disparities. This webinar will address current artificial intelligence initiatives poised to promote fairness and health equity in optimizing cancer care delivery. This session will be held on April 26, 2023, 2 – 3:30pmEST and co-lead by Dr. Julian Hong of the University of California, San Francisco and Dr. Anant Madabhushi of Emory University. Please view the flyer here.



Click here to register for the webinar

NRG Oncology is pleased to report the scientific articles and abstracts that have appeared or have been presented during the previous week. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.

JOURNAL ARTICLES

Wen J, Wang MC, Hu C. Simultaneous hypothesis testing for multiple competing risks in comparative clinical trials. Stat Med. 2023 Apr 10. doi: 10.1002/sim.9728. Epub ahead of print. PMID: 37035880. Read more.

ACCEPTED ABSTRACTS – ASCO June 2-6, 2023

Guan L, Torres-Saavedra PA, Zhao X, Major MB, Holmes BJ, Nguyen NK, Kumaravelu P, Hodge T, Diehn M, Zevallos J, Emami B, Sagar SM, Morrison W, Schultz C, Caudell JJ, Jones CU, Yom SS, Harris J, Le Q, Hayes DN. Association Between Locoregional Failure And NFE2L2/KEAP1/CUL3 Pathway Mutations In NRG/RTOG 9512: A Randomized Trial Of Hyperfractionation Vs. Conventional Fractionation In T2N0 Glottic Squamous Cell Carcinoma (SCC).

Wefel JS, Karrison TG, Pollack A, Balogh AG, Watkins-Bruner D, Gomella LG, Michalski JM, Hallman MA, Rodrigues GB, Seaward SA, Kuettel MR, Barker JL Jr., Camarata AS, Hopkins JO, Greenberg M, Jones J, Sandler H, Seiferheld WF, Movsas B. Neurocognitive Function Outcomes in NRG/RTOG 0534, the SPPORT trial.

Please note the following upcoming meeting and abstract submission deadlines

UPCOMING MEETINGS

American Association for Cancer Research (AACR); Apr 14-19, 2023; Orlando, FL

American Association for Thoracic Surgery (AATS); May 6-9, 2023; Los Angeles, CA

American College of Radiology (ACR); May 6-10, 2023; Washington, DC

American Society of Clinical Oncology (ASCO); Jun 2-6, 2023; Chicago, IL

ESMO Breast Cancer Annual Congress; May 11-13, 2023; Berlin, Germany

European Society for Radiotherapy and Oncology (ESTRO); May 12-16, 2023;

Vienna, Austria

Society for Clinical Trials (SCT); May 21-24, 2023; Baltimore, MD

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society for Radiation Oncology (ASTRO); Oct 1-4, 2023; Chicago, IL; LBA Jul 12, 2023

ESMO World Congress on Gastrointestinal Cancer; Jun 28-Jul 1, 2023; Barcelona, Spain; LBA Jun 15, 2023

European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey; due to publications committee Apr 24, 2023; meeting submission deadline May 8, 2023; LBA Aug 7, 2023

European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain; due to publications committee Apr 26, 2023; meeting submission deadline May 10, 2023, 9pm CntEurSummerTime (CEST); LBA Sep 14, 2023, 9pm CEST

International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea; due to publications committee Apr 24, 2023; meeting submission deadline May 8, 2023, Abstract & Film; TiP LBA, Aug 21, 2023

International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB Canada; LBA Jul 7, 2023

Radiological Society of North America (RSNA); Nov 27-Dec 1, 2023; Chicago, IL; due to publications committee Apr 19, 2023; meeting submission deadline May 3, 2023, 12 Noon CT